University of Toronto and Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON.
Program in Evidence-Based Care, Ontario Health (Cancer Care Ontario), and Department of Oncology, McMaster University, Hamilton, ON.
Curr Oncol. 2020 Feb;27(1):e43-e52. doi: 10.3747/co.27.5933. Epub 2020 Feb 1.
Previous versions of the guideline from the Program in Evidence-Based Care (pebc) at Ontario Health (Cancer Care Ontario) recommended that the use of high-dose interferon alfa 2b therapy be discussed and offered to patients with resected cutaneous melanoma with a high risk of recurrence. Subsequently, several clinical trials in patients with resected or metastatic melanoma found that immune checkpoint inhibitors and targeted therapies have a benefit greater than that with interferon. It was therefore considered timely for an update to the guideline about adjuvant systemic therapy in melanoma.
The present guideline was developed by the pebc and the Melanoma Disease Site Group (dsg). Based on a systematic review from a literature search conducted using medline, embase, and the Evidence Based Medicine Reviews databases for the period 1996 to 28 May 2019, the Working Group drafted recommendations. The systematic review and recommendations were then circulated to the Melanoma dsg and the pebc Report Approval Panel for internal review; the revised document underwent external review.
For patients with completely resected cutaneous or mucosal melanoma with a high risk of recurrence, the recommended adjuvant therapies are nivolumab, pembrolizumab, or dabrafenib-trametinib for patients with V600E or V600K mutations; nivolumab or pembrolizumab are recommend for patients with wild-type disease. Use of ipilimumab is not recommended. Molecular testing should be conducted to help guide treatment decisions. Interferon alfa, chemotherapy regimens, vaccines, levamisole, bevacizumab, bacillus Calmette-Guérin, and isolated limb perfusion are not recommended for adjuvant treatment of cutaneous melanoma except as part of a clinical trial.
安大略省卫生署（安大略省癌症护理）循证护理计划（pebc）以前的指南版本建议对有高复发风险的皮肤黑色素瘤切除患者讨论并提供使用高剂量干扰素 alfa 2b 治疗。随后，几项针对黑色素瘤切除或转移性黑色素瘤患者的临床试验发现，免疫检查点抑制剂和靶向治疗的获益大于干扰素。因此，及时更新有关黑色素瘤辅助系统治疗的指南是必要的。
本指南由 pebc 和黑色素瘤疾病部位专家组（dsg）制定。根据从 medline、embase 和 Evidence Based Medicine Reviews 数据库进行的文献搜索进行的系统评价，工作组起草了建议。该系统评价和建议随后在黑色素瘤 dsg 和 pebc 报告批准小组内部进行审查；修订后的文件进行了外部审查。
对于完全切除的有高复发风险的皮肤或黏膜黑色素瘤患者，推荐的辅助治疗方法是纳武单抗、帕博利珠单抗或达拉非尼联合曲美替尼治疗 V600E 或 V600K 突变患者；纳武单抗或帕博利珠单抗推荐用于野生型疾病患者。不建议使用伊匹单抗。应进行分子检测以帮助指导治疗决策。干扰素 alfa、化疗方案、疫苗、左旋咪唑、贝伐珠单抗、卡介苗和孤立肢体灌注不推荐用于皮肤黑色素瘤的辅助治疗，除非作为临床试验的一部分。
